Ocular Implant Delivery Systems And Methods

ABSTRACT

Described herein are delivery devices and methods of using the devices for delivering an ocular implant into a suprachoroidal space without use of a goniolens. The delivery device includes a handle including a channel extending from a proximal end of the handle to a distal end of the handle, an applier coupled to the handle, the applier including a blunt distal tip and an elongate, flexible wire insertable through a fluid channel of an ocular implant, and a fiber optic image bundle reversibly inserted through the channel such that the fiber optic image bundle extends to a region proximal to the blunt distal tip of the applier.

REFERENCE TO PRIORITY DOCUMENT

This application is a continuation of U.S. patent application Ser. No.14/165,178, filed Jan. 27, 2014, titled, “Ocular Implant DeliverySystems and Methods;” which in turn claims priority U.S. patentapplication Ser. No. 13/721,941, now U.S. Pat. No. 8,636,647, filed Dec.20, 2012, titled, “Ocular Implant Delivery Systems and Methods;” whichin turn claims priority to U.S. patent application Ser. No. 12/753,494,now U.S. Pat. No. 8,337,393, filed Apr. 2, 2010, titled, “Ocular ImplantDelivery Systems and Methods;” which in turn claims priority to U.S.Provisional Patent Application Ser. No. 61/166,574, filed Apr. 3, 2009,and entitled “Ocular Implant Delivery Systems and Methods.” The priorityof the filing date of Apr. 3, 2009 is hereby claimed, and thedisclosures of each of the abovementioned patent applications are herebyincorporated by reference in their entirety.

BACKGROUND

This disclosure relates generally to methods and devices for use indelivery of devices for the treatment of glaucoma. The mechanisms thatcause glaucoma are not completely known. It is known that glaucomaresults in abnormally high pressure in the eye, which leads to opticnerve damage. Over time, the increased pressure can cause damage to theoptic nerve, which can lead to blindness. Treatment strategies havefocused on keeping the intraocular pressure down in order to preserve asmuch vision as possible over the remainder of the patient's life.

Past treatment includes the use of drugs that lower intraocular pressurethrough various mechanisms. The glaucoma drug market is an approximatetwo billion dollar market. The large market is mostly due to the factthat there are not any effective surgical alternatives that are longlasting and complication-free. Unfortunately, drug treatments need muchimprovement, as they can cause adverse side effects and often fail toadequately control intraocular pressure. Moreover, patients are oftenlackadaisical in following proper drug treatment regimens, resulting ina lack of compliance and further symptom progression.

With respect to surgical procedures, one way to treat glaucoma is toimplant a drainage device in the eye. The drainage device functions todrain aqueous humor from the anterior chamber and thereby reduce theintraocular pressure. The drainage device is typically implanted usingan invasive surgical procedure. Pursuant to one such procedure, a flapis surgically formed in the sclera. The flap is folded back to form asmall cavity and the drainage device is inserted into the eye throughthe flap. Such a procedure can be quite traumatic as the implants arelarge and can result in various adverse events such as infections andscarring, leading to the need to re-operate.

Current devices and procedures for treating glaucoma have disadvantagesand only moderate success rates. The procedures are very traumatic tothe eye and also require highly accurate surgical skills, such as toproperly place the drainage device in a proper location. In addition,the devices that drain fluid from the anterior chamber to asubconjunctival bleb beneath a scleral flap are prone to infection, andcan occlude and cease working. This can require re-operation to removethe device and place another one, or can result in further surgeries.

Methods are known in the art for delivering an implant within the eye.Generally, the methods include providing an elongate applier having atits distal region a piercing member or applier intended to pass throughtissues of the eye. The distal end of the applier is positioned withinthe lumen of the implant to be delivered and is advanced to deliver theimplant to the target location. The connection between the applier andthe implant poses some challenges. The connection needs to be releasablein order to deliver the implant at the target location. The connectionalso needs to be strong enough so as not to inadvertently release theimplant from the end of the applier. Delivery mechanisms intended torelease the implant into a target location of the eye can be bulky andrequire the procedure to be performed “blind,” for example, due tohigher profiles of the release mechanism used.

SUMMARY

There is a need for improved devices and methods for the treatment ofeye diseases such as glaucoma. In particular, there is a need forsimplified, low profile devices for the treatment of glaucoma and otherdiseases using a minimally-invasive delivery system and procedure.

In a first embodiment, disclosed herein is a system for delivering anocular implant having a fluid channel. The system includes a deliverydevice and a fiber optic image bundle. The delivery device includes ahandle component having a proximal end, a distal end, and a channelextending therethrough. The delivery device also includes an appliercoupled to the handle having an elongate, flexible wire insertablethrough the fluid channel of the ocular implant. The fiber optic imagebundle is reversibly insertable through the channel such that the fiberoptic image bundle extends to a region proximal to a distal tip of theapplier.

The system can further include an illumination source that emitsinfrared light including an infrared LED and an infrared flood lamp. Theillumination source can be external to the fiber optic image bundle. Thesystem can further include a second illumination source. The secondillumination source can emit visible light including white incandescentlight, white LED and fiberoptic white light. The system can furtherinclude a first mechanism configured to control the first illuminationsource and a second mechanism configured to control the secondillumination source. The second illumination source control mechanismadjusts the second illumination source independent of the firstillumination source control mechanism and the first illumination source.The system can further include a narrow band pass filter.

The system can further include an imaging device configured to captureimage data in the form of video images, still images or both. Theimaging device can include a hand-held digital microscope, a digitalcamera, a CCD video camera, a low mass camera, or a CMOS chip. Theimaging device can communicate the image data to a digital projectorconfigured to project images in real-time to a small projector screendisplayed near a patient's eye. The region proximal to the distal tip ofthe applier can be between about 3 and 20 millimeters proximal to thedistal tip of the applier. The fiber optic image bundle can furtherinclude one or more lenses. The fiber optic image bundle can provide anobjective angle view of at least about 65 degrees.

The system can further include an elongate member having a flow pathway,at least one inflow port communicating with the flow pathway, and anoutflow port communicating with the flow pathway, wherein the elongatemember is adapted to be positioned in an eye such that the inflow portcommunicates with an anterior chamber and the outflow port communicateswith a suprachoroidal space. The system can be used to position theelongate member into a suprachoroidal space without use of a goniolens.

Also described herein are methods of implanting an ocular device intothe eye. In an embodiment, disclosed is a method including loading animplant having a fluid passageway onto a delivery device having anapplier and a handle component having a channel. The distal end of thefiber optic image bundle is positioned proximal to a distal end of theapplier. The method also includes feeding a fiber optic image bundlethrough the channel, forming an incision in the cornea of the eye,inserting the implant loaded on the applier through the incision into ananterior chamber of the eye, passing the implant along a pathway fromthe anterior chamber into a suprachoroidal space, positioning at least aportion of the implant into the suprachoroidal space such that a firstportion of the fluid passageway communicates with the anterior chamberand a second portion of the fluid passageway communicates with thesuprachoroidal space to provide a fluid passageway between thesuprachoroidal space and the anterior chamber, and removing the implantfrom the applier.

The method also can include reversibly inserting the distal end of thefiber optic image bundle through the channel of the handle component toa position proximal to the distal end of the applier. Feeding the fiberoptic image bundle can include reversibly inserting the distal end ofthe fiber optic image bundle through the channel of the handle componentto a position between about 3-20 millimeters proximal to the distal endof the applier. Feeding the fiber optic image bundle can includereversibly inserting the distal end of the fiber optic image bundlethrough the channel of the handle component to about 6 millimetersproximal to the distal end of the applier. The fiber optic image bundlecan be less than about 0.5 millimeters in diameter.

Inserting the implant loaded on the applier through the incision intothe anterior chamber of the eye can include inserting the implant loadedon the applier and the fiber optic image bundle through a singleincision in the cornea into the anterior chamber of the eye. Forming anincision can include forming an incision that is a self-sealingincision. Passing the implant along a pathway from the anterior chamberinto the suprachoroidal space can include bluntly dissecting between atissue boundary of a region of the sclera and a tissue boundary of aregion of a ciliary body. The applier can further include a retentionlayer surrounding an outer surface of the applier comprised of acompliant polymer providing a reversible interference fit between theapplier and the implant.

The method can include providing an illumination source to illuminatethe eye during implantation, wherein the illumination source is externalto the fiber optic image bundle and can emit infrared light. The methodcan include providing a second illumination source to illuminate the eyeduring implantation, wherein the second illumination source emits whitelight. The second illumination source can be adjusted independently ofthe first illumination source.

Other features and advantages should be apparent from the followingdescription of various embodiments, which illustrate, by way of example,the principles of the described subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional, perspective view of a portion of the eyeshowing the anterior and posterior chambers of the eye.

FIG. 2 is a cross-sectional view of a human eye.

FIG. 3A shows an exemplary delivery system that can be used to deliveran implant into the eye.

FIG. 3B shows another embodiment of a delivery system that can be usedto deliver an implant into the eye.

FIGS. 3C and 3D show the delivery system of FIG. 3B during actuation.

FIGS. 4A-4D show an exemplary mechanism for delivering an implant intothe eye.

FIG. 4E is a cross-sectional view of an embodiment of a delivery system.

FIG. 4F is a cross-sectional view of the delivery system of FIG. 4Ataken along line F-F.

FIGS. 4G-4J are schematic views of a distal tip of an applier accordingto various embodiments.

FIGS. 5A-5D show a fiber optic visualization and delivery systemaccording to one embodiment.

FIG. 6A shows an embodiment of a fiber optic visualization and deliverysystem.

FIG. 6B shows another embodiment of a fiber optic visualization anddelivery system.

FIG. 7 shows a schematic of the fiber optic visualization and deliverysystem positioned for penetration into the eye.

FIG. 8 shows an enlarged view of a portion of the anterior region of theeye in cross-section.

FIG. 9 shows an implant positioned within the eye.

It should be appreciated that the drawings herein are exemplary only andare not meant to be to scale.

DETAILED DESCRIPTION

There is a need for improved methods and devices for the treatment ofeye diseases. In particular, there is a need for low profile, simplifieddelivery devices that can be used to deliver implants or other devicesas well as drugs and other therapeutic material into the eye for thetreatment of glaucoma and other diseases. The delivery devices describedherein deliver an implant using an applier that can gently and bluntlydissect between tissue margins or tissue layer boundaries, for example,between the iris root and the scleral spur or the iris root part of theciliary body and the scleral spur into the supraciliary space. Theapplier of the delivery devices described herein may further dissectbetween the sclera and the choroid into the suprachoroidal space in theeye. The applier can penetrate certain tissues and separate tissueboundaries while avoid penetrating certain other tissues. The deliverydevice described herein can include a readily reversible, low-profile,internal retention system between the applier and the implant such thatthe implant can be delivered to the target location in the eye and avoidinadvertent release of the implant during delivery. The delivery devicesdescribed herein also can include a low profile visualization system andillumination system for use during implantation.

FIG. 1 is a cross-sectional, perspective view of a portion of the eyeshowing the anterior and posterior chambers of the eye. A schematicrepresentation of an implant 105 is positioned inside the eye such thata proximal end 110 is located in the anterior chamber 115 and a distalend 120 extends to a region of the eye that is between the ciliary bodyand the sclera. Alternatively, the distal end 120 can extend to a regionof the eye that is posterior to the ciliary body, such as between thechoroid and the sclera. The suprachoroidal space (sometimes referred toas the perichoroidal space) can include the region between the scleraand the choroid. The suprachoroidal space can also include the regionbetween the sclera and the ciliary body. In this regard, the region ofthe suprachoroidal space between the sclera and the ciliary body maysometimes be referred to as the supraciliary space. The implantsdescribed herein are not necessarily positioned between the choroid andthe sclera. The implants may be positioned at least partially betweenthe ciliary body and the sclera or may be at least partially positionedbetween the sclera and the choroid. In any event, the implant canprovide a fluid pathway for flow of aqueous humor through or along theimplant between the anterior chamber and the suprachoroidal space.

In an embodiment, the implant 105 is an elongate element having one ormore internal lumens through which aqueous humor can flow from theanterior chamber 115 into the suprachoroidal space. The implant 105 canhave a substantially uniform diameter along its entire length, althoughthe shape of the implant 105 can vary along its length (either before orafter insertion of the implant), as described below. Moreover, theimplant 105 can have various cross-sectional shapes (such as a,circular, oval or rectangular shape) and can vary in cross-sectionalshape moving along its length. The cross-sectional shape can be selectedto facilitate easy insertion into the eye. The following applicationsdescribe exemplary implants and are incorporated by reference in theirentirety: U.S. Patent Publication No. 2007-0191863 and U.S. PatentApplication Serial No. 2009-0182421.

Eye Anatomy and Glaucoma

FIG. 2 is a cross-sectional view of a portion of the human eye. The eyeis generally spherical and is covered on the outside by the sclera S.The retina lines the inside posterior half of the eye. The retinaregisters the light and sends signals to the brain via the optic nerve.The bulk of the eye is filled and supported by the vitreous body, aclear, jelly-like substance. The elastic lens L is located near thefront of the eye. The lens L provides adjustment of focus and issuspended within a capsular bag from the ciliary body CB, which containsthe muscles that change the focal length of the lens. A volume in frontof the lens L is divided into two by the iris I, which controls theaperture of the lens and the amount of light striking the retina. Thepupil is a hole in the center of the iris I through which light passes.The volume between the iris I and the lens L is the posterior chamberPC. The volume between the iris I and the cornea is the anterior chamberAC. Both chambers are filled with a clear liquid known as aqueous humor.

The ciliary body CB continuously forms aqueous humor in the posteriorchamber PC by secretion from the blood vessels. The aqueous humor flowsaround the lens L and iris I into the anterior chamber and exits the eyethrough the trabecular meshwork TM, a sieve-like structure situated atthe corner of the iris I and the wall of the eye (the corner is known asthe iridocorneal angle). Some of the aqueous humor filters through thetrabecular meshwork near the iris root into Schlemm's canal, a smallchannel that drains into the ocular veins. A smaller portion rejoins thevenous circulation after passing through the ciliary body and eventuallythrough the sclera (the uveoscleral route).

Glaucoma is a disease wherein the aqueous humor builds up within theeye. In a healthy eye, the ciliary processes secrete aqueous humor,which then passes through the angle between the cornea and the iris.Glaucoma appears to be the result of clogging in the trabecularmeshwork. The clogging can be caused by the exfoliation of cells orother debris. When the aqueous humor does not drain properly from theclogged meshwork, it builds up and causes increased pressure in the eye,particularly on the blood vessels that lead to the optic nerve. The highpressure on the blood vessels can result in death of retinal ganglioncells and eventual blindness.

Closed angle (acute) glaucoma can occur in people who were born with anarrow angle between the iris and the cornea (the anterior chamberangle). This is more common in people who are farsighted (they seeobjects in the distance better than those which are close up). The iriscan slip forward and suddenly close off the exit of aqueous humor, and asudden increase in pressure within the eye follows.

Open angle (chronic) glaucoma is by far the most common type ofglaucoma. In open angle glaucoma, the iris does not block the drainageangle as it does in acute glaucoma. Instead, the fluid outlet channelswithin the wall of the eye gradually narrow with time. The diseaseusually affects both eyes, and over a period of years the consistentlyelevated pressure slowly damages the optic nerve.

As shown in FIG. 1, the implant 105 can be an elongate member having aproximal end, a distal end, and a structure that permits fluid (such asaqueous humor) to flow along the length of the implant such as throughor around the implant from the anterior chamber to the suprachoroidalspace. The implant 105 can include at least one internal lumen having atleast one opening for ingress of fluid. In addition to serving as apassageway for the flow of aqueous humor through the implant 105directly from the anterior chamber to the suprachoroidal space, theinternal lumen of the implant can be used as an access location to mountthe implant 105 onto a delivery system, as described in more detailbelow. The internal lumen can also be used as a pathway for flowingirrigation fluid into the eye generally for flushing or to maintainpressure in the anterior chamber, or using the fluid to hydraulicallycreate a dissection plane into or within the suprachoroidal space aswill be discussed in more detail below.

Delivery System

In an embodiment, a delivery system is used to deliver an implant 105into the eye such that the implant 105 provides fluid communicationbetween the anterior chamber and the suprachoroidal space. FIG. 3A showsan embodiment of a delivery system 305 that can be used to deliver theimplant 105 into the eye. FIGS. 3B, 3C and 3D show another embodiment ofa delivery system 305 that can be used to deliver the implant 105 intothe eye. It should be appreciated that these delivery systems 305 areexemplary and that variations in the structure, shape and actuation ofthe delivery system 305 are possible.

The delivery system 305 generally includes a proximal handle component310 and a distal delivery component 320. The proximal handle component310 can include an actuator 420 to control the release of an implantfrom the delivery component 320 into the target location in the eye. Theactuator 420 can vary in structure and mechanism and can include, forexample, a button, switch, knob, slider, etc. The proximal handlecomponent 310 also can include a channel 425 for insertion of avisualization system, such as a fiber optic image bundle 415, to bedescribed in more detail below.

The delivery component 320 includes an elongate applier 515 that insertslongitudinally through the internal lumen of the implant 105 and asheath 510 that can be positioned axially over the applier 515. Thesheath 510 aids in the release of the implant 105 from the deliverycomponent 320 into the target location in the eye. As best shown inFIGS. 3C and 3D, the actuator 420 can be used to control the applier 515and/or the sheath 510. For example, the sheath 510 can be urged in adistal direction relative to the applier 515 to push the implant 105 offthe distal end of the applier 515. Alternately, the sheath 510 can befixed relative to the handle component 310. In this embodiment, thesheath 510 can act as a stopper that impedes the implant 105 from movingin a proximal direction as the applier 515 is withdrawn proximally fromthe implant 105 upon actuation of the actuator 420. In a first stateshown in FIG. 3C, the applier 515 is extended distally relative to thesheath 310. Movement of the actuator 420, such as in the proximaldirection, can cause the applier 515 to slide proximally into the sheath510 as shown in FIG. 3D. This effectively disengages the implant 105from the distal end of the applier 515 and releases the implant 105 in acontrolled fashion such that the target positioning of the implant 105within the suprachoroidal space is maintained.

Internal Implant Retention Layer

The outer diameter of the applier 515 is generally smaller than theinner diameter of the implant 105 (i.e. the fluid channel) such that theimplant 105 can be loaded onto the applier 515 such as by sliding theapplier 515 into and through the internal lumen of the implant 105. Insome instances, the outer diameter of the applier 515 can besignificantly smaller thereby creating a gap G between the applier 515and the implant 105 (see FIG. 4E). This gap G leaves room for adding aretention layer 512 or a retention coating to the delivery component 320(see FIG. 4F). The retention layer 512 can act to retain the implant 105on the applier 515 during blunt dissection and implantation to preventthe implant 105 from inadvertently falling off the applier 515 until itis delivered to the desired target location within the eye. An advantageof a retention layer 512 between the implant and the applier is the verylow profile of the delivery system 305 and a user's improved ability tovisualize each step of implantation. Retention layers added externallyaround the implant, in contrast, significantly increase the profile ofthe delivery device and negatively impact the user's ability tovisualize the steps of delivery. External retention layers can alsoincrease the size of the incision needed to insert the delivery device.

FIGS. 4A-4D show cross-sectional schematic views of an implant 105mounted on a delivery portion 320 inserted from the anterior chamberinto a region of the suprachoroidal space. The figures show an implant105 mounted on the end of an applier 515, a sheath 510 sized and shapedto receive or abut a portion of the proximal end 125 of the implant 105,and a retention layer 512 providing an interference fit between theimplant 105 and the applier 515. In this embodiment upon actuation theapplier 515 slides in the proximal direction (arrow P) into the sheath510. The proximal end 125 of the implant 105 abuts the distal edge ofthe sheath 510 to prevent the implant 105 from sliding in the proximaldirection. This effectively disengages the implant 105 from the distalend of the applier 515 and controllably releases the implant 105 into aregion of the suprachoroidal space SC. The retention layer 512 moveswith the applier 515 such that the applier 515 and retention layer 512are fully withdrawn into the sheath 510. It should be appreciated thatthe sheath 510 can also advanced distally over the applier 515 uponactuation to deliver the implant 105 into the suprachoroidal space.

The retention layer 512 can include, for example, a sleeve such as ashrink-to-fit tube that can be inserted over the applier 515. Theretention layer 512 can also be inserted through the fluid pathway ofthe implant 105. The retention layer 512 can also include a coating ofmaterial, for example on the outer diameter of the applier 515 or on theinner diameter of the implant 105. The retention layer 512 can alsoserve to prevent tissue from jamming into the gap G between the applier515 and implant 105, for example during insertion of the device throughthe iris root or the ciliary body.

The retention layer 512 can be a variety of materials. In an embodiment,the retention layer 512 can be a generally soft, elastomeric, compliantpolymer. For example, the material of the retention layer 512 caninclude silicone, thermoplastic elastomers (HYTREL, RATON, PEBAX),certain polyolefin or polyolefin blends, elastomeric alloys,polyurethanes, thermoplastic copolyester, polyether block amides,polyamides (such as Nylon), block copolymer polyurethanes (such asLYCRA). Some other exemplary materials include fluoropolymer (such asFEP and PVDF), FEP laminated into nodes of ePTFE, acrylic, low glasstransition temperature acrylics, and hydrogels. It should also beappreciated that stiffer polymers can be made to be more compliant byincorporating air or void volumes into their bulk, for example, PTFE andexpanded PTFE.

Dissection Dynamics of Applier

As described above, the delivery component 320 can include an elongateapplier 515. The shape, structure, materials and/or material propertiesof the applier 515 can be selected to optimize the gentle, bluntdissection between the tissue boundaries adjacent to the inner wall ofthe sclera and formation of the suprachoroidal space. The applier 515can have a cross-sectional size and shape that complements thecross-sectional size and/or shape of the internal lumen of the implant105 through which the applier 515 extends when the implant 105 is loadedthereon.

A variety of parameters including the shape, material, materialproperties, diameter, flexibility, compliance, pre-curvature and tipshape of the applier 515 can impact the performance of the applier 515during gentle, blunt tissue dissection. The applier 515 desirably canpenetrate certain tissues while avoids penetration of other tissues. Forexample, in an embodiment, it is desirable that the applier 515 becapable of penetrating the iris root or the ciliary body. The sameapplier 515 would beneficially be incapable of penetrating the scleralspur or inner wall of the sclera such that it can gently dissect betweenthe tissue boundaries adjacent to the inner wall of the sclera. In anembodiment, the scleral spur can be penetrated during delivery. Ifpenetration of the scleral spur does occur, penetration through thescleral spur can be accomplished in various manners. In one embodiment,a sharpened distal tip of the applier or the implant punctures,penetrates, dissects, pierces or otherwise passes through the scleralspur toward the suprachoroidal space. The crossing of the scleral spuror any other tissue can be aided such as by applying energy to thescleral spur or the tissue via the distal tip of the applier. The meansof applying energy can vary and can include mechanical energy, such asby creating a frictional force to generate heat at the scleral spur.Other types of energy can be used, such as RF laser, electrical, etc.

The shape of the applier 515 along its long axis can be straight (asshown in FIG. 3A) or it can be can be curved along all or a portion ofits length (as shown in FIGS. 3B, 3C and 3D) in order to facilitateproper placement. In the case of the curved applier 515, the radius ofcurvature can vary. For example, the applier 515 can have a radius ofcurvature of 3 mm to 50 mm and the curve can cover from 0 degrees to 180degrees. In one embodiment, the applier 515 has a radius of curvaturethat corresponds to or complements the radius of curvature of a regionof the eye, such as curvature of the inner wall of the sclera. Forexample, the radius of curvature can be approximately 11-12 mm.Moreover, the radius of curvature can vary moving along the length ofthe applier 515. There can also be means to vary the radius of curvatureof portions of the applier 515 during placement.

The distal tip shape of the applier 515 can play a part in whether ornot the applier 515 penetrates certain tissues. For example, the scleralwall is a tougher tissue than the ciliary body or the iris root andgenerally requires a sharp-tipped applier in order to be penetrated. Thedistal tip of the applier 515 can be sharp enough to penetrate the irisroot or the ciliary body, but not so sharp (or sufficiently dull) so asnot to easily penetrate the inner wall of the sclera. The tip shape ofthe applier 515 can vary. As shown in FIGS. 4G-4J, the distal tip of theapplier 515 described herein can have a broad angle tip. The tip shapecan be symmetrical relative to a central, longitudinal axis of theapplier, such as a hemispheric tip, blunt-tipped cone, rounded-off conetip, etc. . . . The tip shape can also be asymmetrical such as a shovelor spade shape tip. In an embodiment the applier 515 has a blunt tip.The blunt or atraumatic tip shape aids in the gentle dissection betweentissues, such as the sclera and the ciliary body and the sclera and thechoroid if such dissection occurs.

The distal tip of the applier 515 can also be coated to reduce frictionduring dissection. In an embodiment, the distal tip of the applier 515is coated with a hydrophilic coating such as HYDAK (Biocoat, Horsham,Pa.) or another slippery coating as is known in the art. A balance canbe struck between the angle of the distal tip, the angle of approach tothe dissection entry point and whether or not the tip is covered by aslippery coating such that the risk of penetrating certain tissues (i.e.inner wall of the sclera) is reduced while the ability to penetrateother tissues (i.e. iris root or ciliary body) is maintained.

In addition to tip shape, coatings and pre-curvature of the applier 515,specific dissection performance also depends in part on the complianceand flexibility of the applier 515. The compliance and flexibility ofthe applier 515 is generally a function of the material, materialproperties and diameter of the material selected for the applier. Asmentioned above, it can be desirable to have an applier 515 that doesnot easily penetrate tissues such as the inner wall of the sclera. Butit can also be desirable to have an applier 515 that can penetratethrough other tissues such as the iris root or the ciliary body.Similarly, it can be desirable to have an applier 515 that can hug thecurve of the inner scleral wall during blunt tissue dissection. Theapplier 515 described herein is designed such that it can penetratetissues that the user wants to penetrate, but does not easily penetratetissues that the user wants to avoid penetrating.

The outer diameter of the applier 515 can be selected and optimizedbased on the material and flexibility of the material used for theapplier 515. An applier made of nitinol, for example, can have an outerdiameter of about 0.009 inches. Nitinol is a superelastic metal that isquite bendable yet is stiff enough to be pushed through the iris rootand the ciliary body to reach to and hug the curve of the inner scleralwall during blunt dissection along the boundary between the sclera andthe adjacent tissues to the inner scleral wall. When combined with otherfeatures of the applier, for example a blunt tip, a nitinol applierhaving an outer diameter of about 0.009 inches can be used to gentlydissect the tissue layers while avoiding tunneling or piercing one orboth the inner scleral wall and choroid. Stainless steel spring wire isanother material that could be used for the applier 515. Stainless steelwire is generally slightly stiffer than nitinol. Thus, the outerdiameter of an applier made of stainless steel wire may need to besomewhat smaller than the outer diameter for an applier made of nitinolin order to achieve the same performance during blunt dissection. In anembodiment, the applier has an outer diameter of about 0.0017 inches. Itshould be appreciated that for a given material's flexibility, theoptimum outer diameter of the applier can be determined and extrapolatedfor an applier of a different material having a different degree offlexibility. Other materials considered for the applier 515 includecompliant flexible wires made from a polymer or a polymer composite wirereinforced with high-strength fibers.

Visualization System

Challenges exist with respect to visualization during implantationprocedures such as described herein. Structures near the angle of theeye are hidden from ordinary or direct view because of total internalreflection of light rays emanating from the angle structures. Typicallya gonioscope or viewing lens is needed to view the angle of the eye, forexample during implantation of a device into the suprachoroidal space.The delivery systems described herein need not be used in conjunctionwith a gonioscope or viewing lens. The delivery systems described hereincan include an internal visualization system that eliminates the needfor a gonioscope.

FIGS. 5A-5D and 6A-6B show an embodiment of a delivery system 305 havingan internal imaging system 430. The fiber optic image bundle and lensimaging system is very tiny and has a low profile such that the overalllow profile of the delivery system 305 is maintained and trauma to theeye is minimized. The size and profile of the fiber optic image bundle415 is such that it maintains the advantages described above withrespect to the low profile applier and internal retention system. In anembodiment, the fiber optic image bundle 415 is less than 0.5 mm indiameter. In an embodiment, the fiber optic image bundle 415 can includea coherent fiber optic bundle 705 surrounded by a fiber optic sheath 710or cladding.

As described above, the delivery system 305 can include a channel 425 inits handle component 310 through which a tiny fiber optic image bundle415 can be inserted providing visualization to the delivery component320. The fiber optic image bundle 415 can be inserted into the channel425 through an opening near the proximal end of the handle 310component, exit through another opening of the channel 425 near thedistal end of the handle 310. The fiber optic image bundle 415 canemerge from the distal end of the handle 310 under the applier shaftsuch that it aligns coaxially with or parallel and adjacent to theimplant 105 and applier 515.

It should be appreciated that the fiber optic image bundle 415 canreversibly couple with the handle 310. Just as a surgeon can insert thefiber optic image bundle 415 through the channel 425 in the handle 310for use, the surgeon can also withdraw the fiber optic image bundle 415from the channel 425 and handle 310 when not in use or when use of animaging system is not desired. The reversible connection of the fiberoptic image bundle 415 through the channel 425 provides a surgeon with agood deal of flexibility in that the user decides whether or not to usethe visualization system during implantation procedures. The deliverydevice can be manufactured and provided to a surgeon with the fiberoptic image bundle already installed through the handle 310 of thedevice. In this embodiment, the surgeon can still remove the fiber opticimage bundle 415 from the handle 310 if the surgeon chooses.Alternatively, the delivery device can be manufactured as part of a kitthat includes a fiber optic image bundle 415 that is separate from thehandle 310 that can be readily and reversibly inserted through thechannel 425 to the discretion of the surgeon.

Still with respect to FIGS. 5A-5D, 6A and 6B the fiber optic imagebundle 415 can be fed through the channel 425 until its distal tip ispositioned a distance proximal to the distal tip of the applier 515where the implant 105 is mounted on the applier 515 providing anobjective angle view to the surgeon. The fiber optic image bundle 415can extend towards the distal tip of the applier 515 (see FIG. 5C), forexample such that it is positioned a few millimeters away from thedistal tip of the applier 515. The fiber optic image bundle 415 can bepositioned near the distal tip of the applier 515 such that it providesadequate visualization and, optionally, internal illumination, at theimplantation site, but is not positioned so close to the distal tip thatit interferes with the surgical field where the implant 105 is to beinserted and the gentle dissection of the tissues is desired. The visualperspective from the fiber optic image bundle 415 positioned a fewmillimeters back from the distal tip of the applier 515 can provide anobjective angle, “headlight” type field of view for the surgeon tovisualize the implantation procedure. In an embodiment, the distal tipof the fiber optic image bundle 415 can be positioned between about 3-20mm from the distal tip of the applier 515. In another embodiment, thefiber optic image bundle 415 can be positioned at least about 9 mm fromthe distal tip of the applier 515. In another embodiment, the distal tipof the fiber optic image bundle 415 can be positioned at least about 6mm from the distal tip of the applier 515.

FIG. 5D shows a schematic, enlarged view of the delivery andvisualization system. The fiber optic image bundle 415 is shownpositioned external to the sheath 510 and positioned several millimetersproximal to the distal tip of the applier 515. The applier 515 althoughshown straight can have a slightly curved distal tip near where it abutsthe tissues to be bluntly dissected. It should be appreciated that thedistal tip of the applier remains within the visual field of the imagebundle 415 regardless of whether or not the distal tip is curved. Thefiber optic image bundle 415 can be a coherent bundle of fibers and caninclude one or more lenses 417 near the tip of the image bundle 415. Inan embodiment, two lenses 417 can be separated from one another toprovide a gathering field of view 518, for example, approximately 65degrees from the aqueous side of the distal tip of the applier 515.

As best shown in FIG. 6A-6B, the imaging system 430 can include an imagecapture device 435. The image capture device 435 can be, for example, acamera, a digital microscope (for example, a handheld USB digitalmicroscope, such as a Dino-Lite microscope) or a silicon-based CCD(charge-coupled device) digital color video camera and the like. Theimage capture device 435 can capture images in the infrared (IR)spectrum of light, as will be described in more detail below. Theimaging system 430 can also include a filtering element 455, such as anarrow band pass filter that filters out the visible light from theimage capture device 435 to optimize the IR image captured.

The imaging system 430 can also include an image sensor 445 (see FIG.6B). The image sensor 445 can be a low mass type of camera such as aCMOS (complementary metal oxide semiconductor) chip, for example anOmniVision CMOS CameraChip™ image sensor (OmniVision, Santa Clara,Calif.). The light gathered from the image bundle 415 can be convertedby the image sensor 445 into an electrical signal used by an evaluationmodule (not shown). The imaging system 430 can also include a dataprocessing device 440 such as a PC computer/monitor for collecting,recording and/or viewing image data. In an embodiment, image data(including still images and/or video images) captured by the imagecapture device 435 or image sensor 445 can be processed directly by thedata processing devices 440. The image data can be visualized by thesurgeon in real-time such as on a computer monitor for use during aprocedure. The surgeon can simultaneously view image data, for example,through a surgical microscope (not shown) aided by an externalillumination source in the visible light spectrum as described above.The data processing devices 440 can be adapted to execute image analysissoftware and can include storage means for recording image data.

The imaging system 430 can also include a miniature projector system,such as a DLP® Pico™ Projector Kit (Texas Instruments, Dallas, Tex.).Image data (including still images and/or video images) captured by theimage capture device 435 or image sensor 445 can be projected onto asmall screen that can be positioned near the surgical field or withinone of the oculars of the instrument such that the surgeon can view theimages projected onto the screen without having to look up from thesurgical microscope during the procedure. The projection screen size canvary depending on the configuration used. For example, the projectionscreen can be between about 6″ to about 60″. The projector system can beused in place of a larger video monitor or display that can be mountedinside the operating room, but away from the patient and the surgicalfield.

As mentioned, the visualization system can also include an illuminationsource 450. The illumination source 450 can be used for the imagecapture of the surgical field with an imaging system. The illuminationsource can be internal and combined with the fiber optic image bundle415 such that it is inserted through the same incision as the applier515 and implant 105. It should be appreciated, however that an internalillumination source can have a negative impact on the overall diameterof the delivery component 320. For example, a fiber optic image bundle415 is generally about 0.5 mm in diameter. Adding an illumination source450 to the fiber optic image bundle 415 plus the cladding between thelight source and the image bundle can increase the diameter toapproximately 1.0 mm, necessitating a larger incision in the eye toinsert the delivery component 320. Increased profile of the deliverycomponent can also impact the surgeon's view of the surgical field.Thus, the illumination source 450 can also be separate from the deliverycomponent 320 and inserted through a separate incision in order tomaintain overall small incision size.

In another embodiment the illumination source 450 can be external (see,for example FIGS. 6A and 6B). The external illumination source 450 caninclude an external IR illumination source such as an IR flood lamp, IRlight-emitting diode (LED) or IR LED array. In an embodiment, a whitelight external illumination source can be used such as an incandescentor a white light LED.

The delivery system can use an illumination source 450 for the imagecapture of the surgical field that is independent of the illuminationsource for the surgeon's view of the surgical field. The illuminationsource for image capture of the surgical field with an IR imaging system430 (to be described in more detail below) can be near infrared (IR)light, for example in the 700-1200 nm (0.7-1.2 μm) range. In contrast,the illumination source for the surgeon's view of the surgical field canbe in the visible light spectrum. The modulation controls for the IRsource can be independent of the modulation controls for the white lightsource. Independent illumination modulations between white light and IRlight allow a surgeon to increase the amount of IR light needed tocapture adequate images with the imaging system 430, while the whitelight illumination source can be kept at a comfortable level for boththe surgeon and the patient. The image quality of the surgical fieldusing the imaging system 430 can be optimized (such as by increasing theamount of IR illumination) without negatively impacting the surgeon'sview of the same region using visible light. The dual illuminationsystem of both IR-visible light includes independent modulation controlssuch that one imaging system (i.e. IR imaging system) does not impactthe image achieved by the other imaging system (i.e. surgeon's eyes).

Methods of Implant Delivery

A method of delivering and implanting the implant into the eye is nowdescribed. In general, one or more implants 105 can be slidably mountedon and implanted in or near the suprachoroidal space using a deliverysystem as described herein. The mounting of the implant on the applierof the delivery system can be aided by a retention layer (or a retentioncoating on the applier or the internal walls of the implant) thatreversibly retains the implant on the tip of the applier while stillmaintaining a flexible and low profile applier as described above. Theretention layer can be used to prevent the implant from falling off theapplier inadvertently during delivery until the user actuates thedelivery component and effects controlled release of the implant fromthe applier 515, for example, upon proximal withdrawal of the applier515. The implant 105 can then be secured in the eye so that it providesfluid communication between the anterior chamber and the suprachoroidalspace.

Each step of implantation can be continually visualized in real-timeusing the fiber optic image bundle 415 positioned near the distal end ofthe applier 515 and images of the structures and devices within the eyecan be captured by the imaging system 430. Simultaneously, the images ofthe structures and devices within the eye can be viewed by a surgeonsuch as through a surgical microscope or a computer monitor receivinginput from the imaging system 430. As described above, the independentillumination sources in the IR and white light spectrums can beindependently controlled to allow the surgeon to increase IRillumination in order to obtain the best IR image through the imagingsystem 430 without affecting the physician's own view using the visiblelight illumination source. Visualization can occur continuously duringimplantation or other procedures without the need for re-positioning orremoving one or more components of the imaging systems and without theneed for viewing through a goniolens.

With reference to FIG. 7, the applier 515 is positioned such that thedistal tip, the implant 105 and fiber optic image bundle 415 canpenetrate through a small, corneal incision to access the anteriorchamber. The fiber optic image bundle 415 can be inserted through thesame incision in the cornea as the applier 515 with the implant 105loaded at its distal tip. This provides the advantage that only oneincision is required to deliver the implant and visualize theimplantation procedure. In this regard, the single incision can be madein the eye, such as within the limbus of the cornea. In an embodiment,the incision is very close to the limbus, such as either at the level ofthe limbus or within 2 mm of the limbus in the clear cornea. The applier515 can be used to make the incision or a separate cutting device can beused. For example, a knife-tipped device or diamond knife can be used toinitially enter the cornea. A second device with a spatula tip can thenbe advanced over the knife tip wherein the plane of the spatula ispositioned to coincide with the dissection plane.

The corneal incision has a size that is sufficient to permit passage ofthe implant on the applier as well as the fiber optic image bundle therethrough. In an embodiment, the incision is about 1 mm in size. Inanother embodiment, the incision is no greater than about 2.85 mm insize. In another embodiment, the incision is no greater than about 2.85mm and is greater than about 1.5 mm. It has been observed that anincision of up to 2.85 mm is a self-sealing incision. For clarity ofillustration, the Figures are not to scale.

After insertion through the incision, the applier 515 can be advancedinto the anterior chamber along a pathway that enables the implant 105to be delivered to a position such that the implant 105 provides a flowpassageway from the anterior chamber to the suprachoroidal space. Withthe delivery portion 320 positioned for approach, the applier 515 can beadvanced further into the eye such that the blunt distal tip of theapplier 515 and/or the implant 105 penetrates the tissue at the angle ofthe eye, for example, the iris root or a region of the ciliary body orthe iris root part of the ciliary body near its tissue border with thescleral spur, to be discussed in more detail below.

The scleral spur is an anatomic landmark on the wall of the angle of theeye. The scleral spur is above the level of the iris but below the levelof the trabecular meshwork. In some eyes, the scleral spur can be maskedby the lower band of the pigmented trabecular meshwork and be directlybehind it. The applier can travel along a pathway that is toward theangle of the eye and the scleral spur such that the applier passes nearthe scleral spur on the way to the suprachoroidal space, but does notnecessarily penetrate the scleral spur during delivery. Rather, theapplier 515 can abut the scleral spur and move downward to dissect thetissue boundary between the sclera and the ciliary body, the dissectionentry point starting just below the scleral spur near the iris root IRor the iris root portion of the ciliary body. In another embodiment, thedelivery pathway of the implant intersects the scleral spur. In anembodiment, the scleral spur can be penetrated during delivery. Ifpenetration of the scleral spur does occur, penetration through thescleral spur can be accomplished in various manners. In anotherembodiment, a sharpened distal tip of the applier or the implant canpuncture, penetrate, dissect, pierce or otherwise passes through thescleral spur toward the suprachoroidal space. The crossing of thescleral spur or any other tissue can be aided such as by applying energyto the scleral spur or the tissue via the distal tip of the applier. Themeans of applying energy can vary and can include mechanical energy,such as by creating a frictional force to generate heat at the scleralspur. Other types of energy can be used, such as RF laser, electrical,etc.

The applier 515 can approach the angle of the eye from the same side ofthe anterior chamber as the deployment location such that the applier515 does not have to be advanced across the iris. Alternately, theapplier 515 can approach the angle of the eye from across the anteriorchamber AC such that the applier 515 is advanced across the iris and/orthe anterior chamber toward the opposite angle of the eye. The applier515 can approach the angle of the eye along a variety of pathways. Theapplier 515 does not necessarily cross over the eye and does notintersect the center axis of the eye. In other words, the cornealincision and the location where the implant is implanted at the angle ofthe eye can be in the same quadrant (if the eye is viewed from the frontand divided into four quadrants). Also, the pathway of the implant fromthe corneal incision to the angle of the eye ought not to pass throughthe centerline of the eye to avoid interfering with the pupil.

FIG. 8 shows an enlarged view of the anterior region of the eye showingthe anterior chamber AC, the cornea C, the iris I, and the sclera S. Theimplant 105 mounted on the applier 515 and fiber optic image bundle 415,can approach the angle of the eye from the anterior chamber. They movealong a pathway such that the dissection entry point of the distal tipof the applier 515 can penetrate the iris root IR or the iris rootportion of the ciliary body CB near its junction with the scleral spurSSp. Other penetration points near the angle of the eye are alsoconsidered herein. The surgeon can rotate or reposition the handle ofthe delivery device in order to obtain a proper approach trajectory forthe distal tip of the applier 515, as described in further detail below.

The fiber optic image bundle 415 positioned proximal to the implant 105on the applier 515 provides continuous visualization during delivery ofthe implant 105 to a position that communicates with the suprachoroidalspace SChS. The fiber optic image bundle 415 can be positioned adistance proximal to the distal tip of the applier 515 and provide anobjective angle view to the physician. Although the fiber optic imagebundle 415 can be positioned near the distal tip to provide an objectiveangle view of the implantation site, it does not interfere with thesurgical field where the implant 105 is to be inserted. In anembodiment, the fiber optic image bundle 415 can be between about 3-20mm from the distal tip of the applier 515. In another embodiment, thefiber optic image bundle 415 can be at least about 9 mm from the distaltip of the applier 515. In another embodiment, the fiber optic imagebundle 415 can be at least about 6 mm from the distal tip of the applier515.

The applier 515 with the implant 105 positioned thereupon can beadvanced through tissues near the angle of the eye, such as the irisroot IR, the ciliary body or the iris root portion of the ciliary body.As the applier 515 is advanced it can penetrate an area of fibrousattachment 805 between the scleral spur and the ciliary body (see FIG.8). This area of fibrous attachment 805 can be approximately 1 mm inlength. Once the distal tip of the applier 515 penetrates and is urgedpast this fibrous attachment region 805, it then can more easily causethe sclera S to peel away or otherwise separate from the ciliary bodyand choroid as it follows the inner curve of the sclera to form thesuprachoroidal space SChS. As described above, a combination of theapplier's tip shape, material, material properties, diameter,flexibility, compliance, coatings, pre-curvature etc. make it moreinclined to follow an implantation pathway that mirrors the curvature ofthe inner wall of the sclera and between tissue layers such as betweenthe sclera S and the ciliary body, and between the sclera and thechoroid.

The applier 515 can be continuously advanced into the eye, for exampleapproximately 6 mm. The dissection plane of the applier 515 can followthe curve of the inner scleral wall such that the implant 105 mounted onthe applier 515, for example after penetrating the iris root or the irisroot portion of the ciliary body, can bluntly dissect the boundarybetween tissue layers of the scleral spur SSp and the ciliary body CBsuch that a distal region of the implant extends through thesuprachoroidal space SchS and then, further on, is positioned betweenthe tissue boundaries of the sclera and the choroid forming thesuprachoroidal space. In an embodiment, the implant 105 is positionedsuch that it does not extend past the scleral spur SSp far enough toreach or otherwise contact the choroid. That is, the distal end of theimplant does not reach and cannot contact the choroid. In anotherembodiment, the implant 105 extends sufficiently past the scleral spurSSp such that it is positioned between the tissue boundaries of thesclera and the choroid.

FIG. 9 shows the implant 105 positioned within the suprachoroidal spaceSChS. For clarity of illustration, FIG. 9 does not show the implant 105mounted on the applier 515, although the implant 105 is mounted on theapplier 515 during delivery. A first portion of the implant 105 can bepositioned within the suprachoroidal space and a second portion of theimplant 105 can remain within the anterior chamber AC. In oneembodiment, at least 1 mm to 2 mm of the implant (along the length)remains in the anterior chamber AC.

The implant 105 can be positioned in the eye so that a portion of theimplant is sitting on top of the ciliary body CB. The ciliary body CBcan act as a platform off of which the implant 105 can cantilever intothe suprachoroidal space SChS. The implant 105 can have a relativestiffness such that, when implanted, the implant 105 deforms at least aportion of the tissue adjacent the suprachoroidal space to take on ashape that is different than the natural curvature. In this manner, theimplant 105 can lift or “tent” the sclera S outward such that thesuprachoroidal space SchS is formed around the distal end of the implant105. The tenting of the sclera S as shown in FIG. 9 has been exaggeratedfor clarity of illustration. It should be appreciated that the actualcontour of the tented region of tissue may differ in the actual anatomy.Whether the distal end of the implant 105 is positioned between thesclera and the ciliary body or the sclera and the choroid, the implant105 can act as a flow pathway between the anterior chamber AC and thesuprachoroidal space SchS without blockage of the outflow pathway bysurrounding tissues such as the sclera or the choroid. As mentioned, inan embodiment the distal end of the implant 105 does not extend farenough to reach the choroid. In another embodiment, the distal end ofthe implant 105 reaches the choroid and may contact the choroid.

Once properly positioned, the implant 105 can then be released. Theimplant 105 can be released for example by withdrawing the applier 515such that the implant 105 is effectively disengaged in a controlledmanner from the tip of the applier 515 with the sheath 510 (for examplevia the manner described above with reference to FIGS. 4A-4D). Aretention layer 512 can optionally be used to assist in retaining theimplant 105 on the applier 515 during the steps of delivery. However,the relationship between the retention layer 512 and the implant 105 isreadily reversible such that the applier 515 and retention layer 512 canbe withdrawn into the sheath 510 to controllably release the implant 105from the tip of the applier upon arrival at the target location withinthe eye.

The implant 105 can include one or more structural features that aid toanchor or retain the implant 105 in the target region in the eye. Thestructural features can include flanges, protrusions, wings, tines, orprongs, and the like that can lodge into the surrounding eye anatomy toretain the implant 105 in place and prevent the implant 105 from movingfurther into the suprachoroidal space SchS. The structural features alsoprovide regions for areas of fibrous attachment between the implant 105and the surrounding eye anatomy. FIG. 9 illustrates schematically anapproximately 1 mm circumferential band 107 of the implant 105 near thejunction of the iris root and the scleral spur along the inside of thescleral wall toward the back of the eye at which fibrous attachment canoccur. Fibrous attachment can result, for example, from endothelial cellgrowth in, around and/or between retention features of the implant 105.In addition, a small amount of scaring in and around an area of fibroustissue attachment between the scleral spur and the ciliary body in theregion of the iris root portion of the ciliary body can provide foradditional fixation to prop up the implant in its target location.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of an invention that is claimed orof what may be claimed, but rather as descriptions of features specificto particular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

What is claimed is:
 1. A system for delivering an ocular implant havinga fluid channel, the system comprising: a delivery device comprising: ahandle component having a proximal end, a distal end; and a flexiblewire coupled to the handle and insertable through a fluid channel of anocular implant; and a retention element on the flexible wire, theretention element providing an interference fit between an implant andthe flexible wire when an implant is inserted on the flexible wire. 2.The system of claim 1, further comprising a fiber optic image bundlereversibly insertable through the handle such that the fiber optic imagebundle extends to a region proximal to a distal tip of the flexiblewire.
 3. The system of claim 2, further comprising an illuminationsource that emits infrared light selected from the group comprising aninfrared LED and an infrared flood lamp.
 4. The system of claim 3,wherein the illumination source is external to the fiber optic imagebundle.
 5. The system of claim 3, further comprising a secondillumination source.
 6. The system of claim 5, wherein the secondillumination source emits visible light selected from the groupcomprising white incandescent light, white LED and fiberoptic whitelight.
 7. The system of claim 5, further comprising a first mechanismconfigured to control the first illumination source and a secondmechanism configured to control the second illumination source, whereinthe second illumination source control mechanism adjusts the secondillumination source independent of the first illumination source controlmechanism and the first illumination source.
 8. The system of claim 3,further comprising a narrow band pass filter.
 9. The system of claim 3,further comprising an imaging device configured to capture image data inthe form of video images, still images or both.
 10. The system of claim9, wherein the imaging device is selected from the group comprising ahand-held digital microscope, a digital camera, a CCD video camera, alow mass camera, and a CMOS chip.
 11. The system of claim 9, wherein theimaging device communicates the image data to a digital projectorconfigured to project images in real-time to a small projector screendisplayed near a patient's eye.
 12. The system of claim 2, wherein theregion proximal to the distal tip of the flexible wire is between about3 and 20 millimeters proximal to the distal tip of the flexible wire.13. The system of claim 2, wherein the fiber optic image bundle furthercomprises one or more lenses.
 14. The system of claim 2, wherein thefiber optic image bundle provides an objective angle view of at leastabout 65 degrees.
 15. The system of claim 1, further comprising theimplant comprising an elongate member having a flow pathway, at leastone inflow port communicating with the flow pathway, and an outflow portcommunicating with the flow pathway, wherein the elongate member isadapted to be positioned in an eye such that the inflow portcommunicates with an anterior chamber and the outflow port communicateswith a suprachoroidal space.
 16. The system of claim 15, wherein theelongate member is positioned into a suprachoroidal space without use ofa goniolens.